Campania Preventability Assessment Committee (Italy): A Focus on the Preventability of Non-steroidal Anti-inflammatory Drugs' Adverse Drug Reactions

Abstract

Purpose: This study aims to investigate preventability criteria of adverse drug reactions (ADRs) involving non-steroidal anti-inflammatory drugs (NSAIDs) by analyzing individual case safety reports (ICSRs) sent through Campania region (Italy) spontaneous reporting system from July 2012 to October 2016.Methods: For all the ICSRs that reported NSAIDs as suspected drug, a trained multidisciplinary team of Campania Pharmacovigilance Regional Centre composed of clinical pharmacologists and pharmacists with pluriannual experience in Pharmacovigilance assessed preventability by using the P-method.Results: In all 19,039 ICSRs were sent to Campania Pharmacovigilance Regional Centre, of which 550 reported NSAIDs as suspected drug. In total, 94 cases (17.1%) out of 550 ICSRs were preventable. In the 94 preventable cases, 201 critical criteria were detected of which 182/201 (90.5%) related to healthcare professionals' practices, 0/201 (0.0%) to drug quality, and 19/201 (9.5%) to patient behavior. The most detected critical criteria were the necessary medication not given (52/182; 28.6%), labeled drug–drug interaction (36/182; 19.7%), incorrect drug administration duration (31/182; 16.9%), wrong indication (26/182; 14.2%), therapeutic duplication (18/182; 10.0%), and documented hypersensitivity to administered drug or drug class (10/182; 5.6%). In seventeen (18.1%) preventable cases, there were 19 critical criteria involving non-compliance (15/19 critical criteria; 78.9%) and self-medication with the non-over-the-counter drugs (4/19 critical criteria; 21.1%). In all, 17 out 94 (18.1%) preventable cases involved over-the-counter drugs.Conclusion: A call for action for Campania Pharmacovigilance Regional Centre is necessary in order to promote initiatives to increase the awareness of healthcare professionals and citizens on the risk associated with inappropriate use of NSAIDs.

Adverse drug reactions during hepatitis C treatment with direct-acting antivirals: The role of medication errors, their impact on treatment discontinuation and their preventability. New insights from the Campania Region (Italy) spontaneous reporting syste

“…The P‐method is a validated algorithm developed to assess the preventability of ADRs using records sent through the spontaneous reporting system; this method is applied by a trained multidisciplinary team composed of clinical pharmacologists with pluriannual experience in Pharmacovigilance as described previously . Cases were classified as potentially preventable if there was at least one critical criterion for preventability in the ICSR.…”

“…The P-method is a validated algorithm developed to assess the preventability of ADRs using records sent through the spontaneous reporting system; this method is applied by a trained multidisciplinary team composed of clinical pharmacologists with pluriannual experience in Pharmacovigilance as described previously. [10][11][12][13] Cases were classified as potentially preventable if there was at least one critical criterion for preventability in the ICSR. However, due to a lack of detail on the method's administration procedures, laboratory monitoring or the use of a pharmacological therapy, identifying associations between the preventability criterion and adverse drug reactions was not possible.…”

“…Accordingly, the World Health Organization promotes activities to detect medication errors that lead to adverse drug reactions (ADRs) by re‐evaluating individual case safety reports (ICSRs) submitted through spontaneous reporting systems. Pharmacovigilance Centers are expected to play a key role in this initiative by promoting appropriate drug use within their regional territory and by identifying risk factors for ADRs as well as low adherence to pharmacological treatments …”

“…[7][8][9] Accordingly, the World Health Organization promotes activities to detect medication errors that lead to adverse drug reactions (ADRs) by re-evaluating individual case safety reports (ICSRs) submitted through spontaneous reporting systems. Pharmacovigilance Centers are expected to play a key role in this initiative [10][11][12][13][14] by promoting appropriate drug use within their regional territory 15 and by identifying risk factors for ADRs as well as low adherence to pharmacological treatments. 16 Despite the availability of a validated method for assessing medication errors reported in ICSRs, none of the Italian Pharmacovigilance Regional Centers to date have utilized these data in studies to evaluate the impact of medication errors involving DAAs.…”

Quinolones-Induced Musculoskeletal, Neurological, and Psychiatric ADRs: A Pharmacovigilance Study Based on Data From the Italian Spontaneous Reporting System

“…Safety data deriving from the Italian spontaneous reporting system are anonymous and in compliance with the ethical standard. Therefore, no further ethical measures were required (Sportiello et al, 2016;Sessa et al, 2017).…”